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Objectives The aim of this study was to evaluate the efficacy of radiofrequency (RF) energy applications targeting the atrial side of a significant residual leak in patients with acute and chronic evidence of incomplete percutaneous left atrial appendage (LAA) occlusion. Background RF applications have been proved to prevent recanalization of intracranial aneurysms after coil embolization, thereby favoring complete sealing. From a mechanistic standpoint, in vitro and in vivo experiments have demonstrated that RF promotes collagen deposition and tissue retraction. Methods Forty-three patients (mean age 75 ± 7 years mean CHA2DS2-VASc score 4.6 ± 1.4, mean HAS-BLED score 4.0 ± 1.1) with residual leaks ≥4 mm after Watchman implantation were enrolled. Procedural success was defined as complete LAA occlusion or presence of a mild or minimal (1- to 2-mm) peridevice leak on follow-up transesophageal echocardiography (TEE), which was performed approximately 45 days after the procedure. Results RF-based leak closure was performed acutely after Watchman implantation in 19 patients (44.2%) or scheduled after evidence of significant leaks on follow-up TEE in 24 others (55.8%). The median leak size was 5 mm (range: 4-7 mm). On average, 18 ± 7 RF applications per patient (mean maximum contact force 16 ± 3 g, mean power 44 ± 2 W, mean RF time 5.1 ± 2.5 minutes) were performed targeting the atrial edge of the leak. Post-RF median leak size was 0 mm (range: 0-1 mm). A very low rate (2.3% [n = 1]) of major periprocedural complications was observed. Follow-up TEE revealed complete LAA sealing in 23 patients (53.5%) and negligible residual leaks in 15 (34.9%). Conclusions RF applications targeting the atrial edge of a significant peri-Watchman leak may promote LAA sealing via tissue remodeling, without increasing complications. (RF Applications for Residual LAA Leaks [REACT]; NCT04726943 )

Objectives This study evaluated the long-term efficacy of a standard antithrombotic strategy versus half-dose direct oral anticoagulation (DOAC) after Watchman implantation. Background No consensus currently exists on the selection of the most effective antithrombotic strategy to prevent device-related thrombosis (DRT) in patients undergoing endocardial left atrial appendage closure. Methods After successful left atrial appendage closure, consecutive patients were prescribed a standard antithrombotic strategy (SAT) or long-term half-dose DOAC (hdDOAC). The primary composite endpoint was DRT and thromboembolic (TE) and bleeding events. Results Overall, 555 patients (mean age 75 ± 8 years, 63% male; median CHA2DS2-VASc [congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65-74 years, sex category] score 4 [interquartile range (IQR): 3-6]; median HAS-BLED [hypertension, abnormal renal or liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol] score 3 [IQR: 2-4]) were included. Patients were categorized into 2 groups (SAT: n = 357 vs hdDOAC: n = 198). Baseline clinical characteristics were similar between groups. The median follow-up duration was 13 months (IQR: 12-15 months). DRT occurred in 12 (2.1%) patients, all in the SAT group (3.4% vs 0.0%; log-rank P = 0.009). The risk of nonprocedural major bleeding was significantly more favorable in the hdDOAC group (0.5% vs. 3.9%; log-rank P = 0.018). The rate of the primary composite endpoint of DRT and TE and major bleeding events was 9.5% in SAT patients and 1.0% in hdDOAC patients (HR: 9.8; 95% CI: 2.3-40.7; P = 0.002). Conclusions After successful Watchman implantation, long-term half-dose DOAC significantly reduced the risk of the composite endpoint of DRT and TE and major bleeding events compared with a standard, antiplatelet-based, antithrombotic therapy.

BACKGROUND Intracardiac electrogram data remain one of the primary diagnostic inputs guiding complex ablation procedures. However, the technology to collect, process, and display intracardiac signals has known shortcomings and has not advanced in several decades. OBJECTIVE The purpose of this study was to evaluate a new signal processing platform, the PURE EP™ system (PURE), in a multi-center, prospective study. METHODS Intracardiac signal data of clinical interest were collected from 51 patients undergoing ablation procedures with PURE, the signal recording system, and the 3D mapping system at the same time stamps. The samples were randomized and subjected to blinded, controlled evaluation by three independent electrophysiologists to determine the overall quality and clinical utility of PURE signals when compared to conventional sources. Each reviewer assessed the same (92) signal sample sets and responded to (235) questions using a 10-point rating scale. If two or more reviewers rated the PURE signal higher than the control, it was deemed superior. RESULTS A total of 93% of question responses showed consensus amongst the blinded reviewers. Based on the ratings for each pair of signals, a cumulative total of 164 PURE signals out of 218 (75.2%) were statistically rated as Superior for this data set (p

Background: Following left atrial appendage (LAA) electrical isolation, the decision on whether to continue oral anticoagulation after successful atrial fibrillation ablation is based on the study of its mechanical function on transesophageal echocardiography (TEE). In this cohort, LAA contraction is absent and the incorrect interpretation of emptying flow velocities can lead to unwanted clinical sequelae. Methods: One hundred and sixty consecutive TEE exams performed to evaluate the LAA mechanical function following its electrical isolation were reviewed by an experienced operator blinded to the original diagnosis of LAA dysfunction. The rate of diagnostic discrepancy in the assessment LAA dysfunction and its clinical implications were evaluated. Results: Diagnostic discrepancy with misclassification of the LAA mechanical function occurred 36% (58/160) of TEE exams. In most cases (57/58), such discrepancy was observed in the setting of an incorrect original diagnosis of a normal LAA mechanical function despite absent/reduced or inconsistent LAA contraction. This main source of this wrong diagnosis was the wrong interpretation of passive LAA flows (34/57; 60%), followed by failure to identify dissociated firing (15/57; 26%). In rare cases (8/57; 14%), velocities of surrounding structures were interpreted as LAA flow due to misplacement of the pulsed-wave Doppler sample volume. Following LAA isolation, the proportion of patients who experienced a cerebrovascular event while off oral anticoagulation due to the misclassification of their LAA mechanical function was 70% (7/10 [95% CI, 40%–89%]). Conclusions: Underdiagnosis of LAA mechanical dysfunction is common in TEEs performed following LAA electrical isolation, and it is associated with an increased risk of cerebrovascular events owing to oral anticoagulation discontinuation despite absent/reduced LAA contraction. Careful review of the TEE exam by an operator with specific expertise in LAA imaging and familiar with the functional implications of LAA isolation is necessary before interrupting oral anticoagulation in this cohort.

In the past decade, the use of interventional electrophysiological (EP) procedures for the diagnosis and treatment of cardiac arrhythmias has exponentially increased. These procedures usually require fluoroscopy to guide the advancement and frequent repositioning of intracardiac catheters, resulting in both the patient and the operator being subjected to a considerable degree of radiation exposure. Although shielding options such as lead gowns, glasses, and pull-down shields are useful for protecting the operator, they do not lessen the patient’s level of exposure. Furthermore, the prolonged use of lead gowns can exponentiate the onset of orthopedic problems among operators. Recent advancements in three-dimensional cardiac mapping systems and the use of radiation-free imaging technologies such as magnetic resonance imaging and intracardiac ultrasound allow operators to perform EP procedures with minimal or even no fluoroscopy. In this review, we sought to describe the state of fluoroless procedures in EP practice.

COVID-19 mainly affects the respiratory system but has been correlated with cardiovascular manifestations such as myocarditis, heart failure, acute coronary syndromes, and arrhythmias. Cardiac arrhythmias are the second most frequent complication affecting about 30% of patients. Several mechanisms may lead to an increased risk of cardiac arrhythmias during COVID-19 infection, ranging from direct myocardial damage to extracardiac involvement. The aim of this review is to describe the role of COVID-19 in the pathogenesis of cardiac arrhythmias and provide a comprehensive guidance for their monitoring and management.

This article has been retracted: please see Elsevier Policy on Article Withdrawal (https://www.elsevier.com/about/our-business/policies/article-withdrawal). This article has been retracted at the request of the authors. The authors inadvertently specified some ablation settings in the methods section that should not have been reported because they can be potentially linked to a specific pulsed field ablation technology that is currently under investigation for FDA approval. The Authors apologize for the inconvenience caused by this oversightinsert 'Reason' text (to be provided by the Editor-in-Chief or written by the Publisher and approved by the Editor-in-Chief and then approved by the RR panel). In case of (suspected) plagiarism, it is mandatory to refer to the plagiarized work here byAbbreviated Journal Title, volume (year) first page - last page, http://dx.doi.org/DOI of plagiarized work (in URL format) coded as inter-ref if possible.

Background We evaluated long‐term outcome of isolation of pulmonary veins, left atrial posterior wall, and superior vena cava, including time to recurrence and prevalent triggering foci at repeat ablation in patients with paroxysmal atrial fibrillation with or without cardiovascular comorbidities. Methods and Results A total of 1633 consecutive patients with paroxysmal atrial fibrillation that were arrhythmia‐free for 2 years following the index ablation were classified into: group 1 (without comorbidities); n=692 and group 2 (with comorbidities); n=941. We excluded patients with documented ablation of areas other than pulmonary veins, the left atrial posterior wall, and the superior vena cava at the index procedure. At 10 years after an average of 1.2 procedures, 215 (31%) and 480 (51%) patients had recurrence with median time to recurrence being 7.4 (interquartile interval [IQI] 4.3–8.5) and 5.6 (IQI 3.8–8.3) years in group 1 and 2, respectively. A total of 201 (93.5%) and 456 (95%) patients from group 1 and 2 underwent redo ablation; 147/201 and 414/456 received left atrial appendage and coronary sinus isolation and 54/201 and 42/456 had left atrial lines and flutter ablation. At 2 years after the redo, 134 (91.1%) and 391 (94.4%) patients from group 1 and 2 receiving left atrial appendage/coronary sinus isolation remained arrhythmia‐free whereas sinus rhythm was maintained in 4 (7.4%) and 3 (7.1%) patients in respective groups undergoing empirical lines and flutter ablation ( P Conclusions Very late recurrence of atrial fibrillation after successful isolation of pulmonary veins, regardless of the comorbidity profile, was majorly driven by non‐pulmonary vein triggers and ablation of these foci resulted in high success rate. However, presence of comorbidities was associated with significantly earlier recurrence.

Objectives This study sought to report the incidence of device-related thrombosis (DRT) and thromboembolic (TE) events when an alternative to clopidogrel is prescribed in loss-of-function (LOF) allele carriers of the cytochrome P450 2C19 (CYP2C19) gene. Background LOF polymorphisms of the CYP2C19 gene are associated with reduced hepatic bioactivation of clopidogrel. Methods One thousand two Watchman patients were included. Six hundred forty-five patients underwent CYP2C19 genetic testing; among patients with clopidogrel resistance, clopidogrel was replaced by either prasugrel (pilot cohort) or half dose direct oral anticoagulant ((DOAC)/Group 1), both in combination with aspirin. We compared the incidence of DRT/TE events among genotyped patients and a control group which received standard dual antiplatelet therapy (DAPT) (Group 2; n = 357). All reported events occurred during a timeframe between 45- and 180-day follow-up transesophageal echocardiograms, when the 2 different antithrombotic strategies (genotype-guided vs standard DAPT) were adopted. Results In the pilot cohort (n = 244), bleeding events occurred in 10.2% of patients who received aspirin plus prasugrel, leading to early discontinuation of the prasugrel-based protocol. DOAC Group 1 patients (n = 401), 25.7% were reduced metabolizers, and clopidogrel was replaced by half dose direct oral anticoagulant. DRT was documented in 1 (0.2%) patient of Group 1 and 7 (1.96%) patients of Group 2 (log-rank P value = 0.021). The composite endpoint of DRT/TE events was significantly lower among patients receiving a genotype-guided antithrombotic strategy (0.75% vs 3.1%; log-rank P value = 0.017). Conclusions In Watchman patients, a genotype-based antithrombotic strategy with aspirin plus half dose DOAC in reduced clopidogrel metabolizers was superior to standard DAPT with respect to DRT/TE events.

Background: Interventional therapies aiming at excluding the left atrial appendage (LAA) from systemic circulation have been established as a valid alternative to oral anticoagulation in patients at high thromboembolic risk. However, their efficacy on stroke prophylaxis may be compromised owing to incomplete LAA closure. Additionally, the need for an alternative thromboembolic prevention may remain unmet in patients with contraindications to oral anticoagulation whose appendage anatomy is unsuitable for some conventional devices commercially available. We aimed at evaluating the feasibility of LAA closure with the novel Gore Cardioform Septal Occluder in patients with incomplete appendage ligation or anatomic features which do not meet the manufacturer’s requirements for Watchman deployment. Methods: Twenty-one consecutive patients (mean age: 72±6 years; 85.7% males; CHA 2 DS 2 -VASc: 4.5±1.4; HAS-BLED: 3.6±1.0) were included. Transesophageal echocardiography was performed within 2 months to assess for residual LAA patency. Results: Fourteen patients had incomplete LAA closure following surgical (n=6) or Lariat ligation (n=8). In 7 patients with an appendage anatomy unsuitable for Watchman deployment, the mean maximal landing zone size and LAA depth were 14.4±1.3 and 18.6±2.8 mm. Successful Cardioform Septal Occluder deployment was achieved in all patients. No peri-procedural complications were documented. Procedure and fluoroscopy times were 46±13 and 14±5 minutes. Follow-up transesophageal echocardiography after 58±9 days revealed complete LAA closure in all patients. Conclusions: Transcatheter LAA closure via a Cardioform Septal Occluder device might be a valid alternative in patients with residual leaks following failed appendage ligation or whose LAA anatomy does not meet the minimal anatomic criteria to accommodate a Watchman device. Graphic Abstract: A graphic abstract is available for this article.

This study sought to compare the effect of high-dose dobutamine (DBT) with that of high-dose isoproterenol (IPN) in eliciting triggers during atrial fibrillation (AF) ablation.High-dose IPN is commonly used to elicit triggers during AF ablation. However, it is not available worldwide and, in the United States, its cost per dose has significantly increased. DBT is a similarly nonselective β-agonist and, as such, is a potential alternative.This was a prospective, randomized 2×2 crossover study of patients undergoing AF ablation. Patients were assigned to receive IPN (20 to 30 μg/min for 10 min) followed by DBT (40 to 50 μg/kg/min for 10 min) or vice versa in a 1:1 fashion. The type, number, and location of triggers as well as heart rate, blood pressure, and side effects were noted.Fifty patients were included in the study. Both drugs caused a significant increase in heart rate, with a consistently lower peak for DBT. Blood pressure significantly increased with DBT, while there was a significant reduction with IPN, despite phenylephrine support. Atrial arrhythmias induced during DBT were comparable to that induced during IPN. In patients with IPN-inducible outflow tract premature ventricular contractions, a similar effect was noted with DBT. No major complications occurred during either drug challenge.High-dose DBT is safe and comparable to high-dose IPN in respect of eliciting AF triggers, with the advantage to maintain systemic pressure without the need of additional vasopressor support. This study supports the use of high-dose DBT in electrophysiology laboratories in which IPN is not readily available and for those patients in whom hypotension is a concern.

Objectives This study sought to characterize ventricular tachycardia (VT) ablation outcomes across nonischemic cardiomyopathy (NICM) etiologies and adjust these outcomes by patient-related comorbidities that could explain differences in arrhythmia recurrence rates. Background Outcomes of catheter ablation of VT in patients with NICM could be related to etiology of NICM. Methods Data from 2,075 patients with structural heart disease referred for catheter ablation of VT from 12 international centers was retrospectively analyzed. Patient characteristics and outcomes were noted for the 6 most common NICM etiologies. Multivariable Cox proportional hazards modeling was used to adjust for potential confounders. Results Of 780 NICM patients (57 ± 14 years of age, 18% women, left ventricular ejection fraction 37 ± 13%), underlying prevalence was 66% for dilated idiopathic cardiomyopathy (DICM), 13% for arrhythmogenic right ventricular cardiomyopathy (ARVC), 6% for valvular cardiomyopathy, 6% for myocarditis, 4% for hypertrophic cardiomyopathy, and 3% for sarcoidosis. One-year freedom from VT was 69%, and freedom from VT, heart transplantation, and death was 62%. On unadjusted competing risk analysis, VT ablation in ARVC demonstrated superior VT-free survival (82%) versus DICM (p ≤ 0.01). Valvular cardiomyopathy had the poorest unadjusted VT-free survival, at 47% (p Conclusions Catheter ablation of VT in NICM is effective. Etiology of NICM is a significant predictor of outcomes, with ARVC, myocarditis, and DICM having similar but superior outcomes to hypertrophic cardiomyopathy, valvular cardiomyopathy, and sarcoidosis, after adjusting for potential covariates.

Objectives This study reports outcomes of bailout atrial balloon septoplasty (ABS) to overcome challenging left atrial (LA) access in patients undergoing atrial fibrillation (AF) ablation. Background Transseptal puncture (TSP) and LA access for AF ablation can be challenging in patients with prior atrial septal surgery, percutaneous closure, or scarred septum due to multiple prior TSPs. Methods The study identified patients who underwent AF ablation at 2 ablation centers from 2011 to 2017 with challenging TSP in whom bailout percutaneous ABS was performed to allow LA access. Following TSP, the transseptal sheath could not be advanced to the LA despite multiple attempts or approaches including use of a stiff wire sequentially in the left and right pulmonary veins, use of a stiff pigtail exchange wire advanced in the LA or left ventricle, or sequential dilation with progressively larger diameter long dilators. ABS was performed using a noncompliant balloon (diameter 4 to 10 mm) advanced over a stiff wire deployed in the left superior pulmonary vein, allowing passage of the transseptal sheaths for completion of the AF ablation procedure. Results Fifteen patients (mean age 54.4 ± 15.5 years, 9 women) with challenging TSP (7 patients with prior surgical ASD repair, 2 with percutaneous ASD closure devices, and 13 with ≥1 previous TSP) underwent bailout ABS for AF ablation. After TSP (radiofrequency assisted in 10 cases), ABS was successful and permitted access to the LA for ablation in all patients. Mean time required to perform ABS was 21.3 ± 19.4 min, and mean total procedure time was 241.1 ± 114.6 min (fluoroscopy time 62.0 ± 29.9 min). There were no procedural complications. Conclusions In patients undergoing AF ablation with difficult transseptal access due to scarred, surgically, or percutaneously repaired atrial septum, ABS is a safe and effective bailout strategy to obtain transseptal access.

The purpose of this study was to evaluate the characteristics and outcome of patients undergoing ablation after electrical storm (ES).Clinical and procedural characteristics, ventricular tachycardia (VT) recurrence, and mortality rates from 1940 patients undergoing VT ablation were compared between patients with and without ES.The group of 677 patients with ES (34.9%) were older, were more frequently men, and had a lower ejection fraction, more advanced heart failure, and a higher prevalence of cardiovascular comorbidities as compared with those without ES (86.1% patients with ES had ≥2 comorbidities vs 71.4%; P.001). Patients with ES had more inducible VTs (2.5 ± 1.8 vs 1.9 ± 1.9; P.001), required longer procedures (296.1 ± 119.1 minutes vs 265.7 ± 110.3 minutes; P.001), and had a higher in-hospital mortality (42 deaths [6.2%] vs 18 deaths [1.4%]; P.001). At 1-year follow-up, patients with ES experienced a higher risk of VT recurrence and mortality (32.1% vs 22.6% and 20.1% vs 8.5%; long-rank, P.001 for both). Among patients with ES, those without any inducible VT after ablation had a higher survival rate (86.3%) than did those with nonclinical VTs only (72.9%), those with clinical VTs inducible at programmed electrical stimulation (51.2%), and not-tested patients (65.0%) (long-rank, P.001 for all). In multivariate analysis, ES remained an independent predictor of in-hospital mortality, VT recurrence, and 1-year mortality (P.001).Patients with ES have a high risk of VT recurrence and mortality. Patient and procedure characteristics are consistent with advanced cardiac disease and longer and more complex procedures. In patients with ES, acute procedural success is associated with a significant reduction in VT recurrence and improved 1-year survival.

BackgroundStereotactic radiosurgery is a form of radiotherapy that is performed in a single session and focuses high-dose ionizing radiation beams from a collimated radiation source to a small, localized area of the body. Recently, stereotactic radiosurgery has been applied to arrhythmias (stereotactic arrhythmia radioablation - STAR), with promising results reported in patients with refractory, scar-related ventricular tachycardia (VT), a cohort with known high morbidity and mortality.ObjectiveHerein, we describe our experience with the use of CyberKnife, a frameless image-guided linear accelerator stereotactic radiosurgery system, in conjunction with CardioPlan, a cardiac specific radiotherapy planning software, to treat patients with scar-related VT, detailing its early and mid-to long-term results.MethodsThis is a pilot, prospective study of patients undergoing STAR for refractory VT. The anatomical target for radioablation was defined based on the clinical VT morphology, electroanatomical mapping, and study-specific pre-procedural imaging with cardiac computed tomography. The target volume delineated with the aid of CardioPlan was treated with a prescription radiation dose of 25 Gy delivered in a single fraction by CyberKnife in an outpatient setting. Ventricular arrhythmias and radiation-related adverse events were monitored at follow-up to determine STAR efficacy and safety.ResultsFive patients (100 % male, 63 ± 12 years old, 80 % ischemic cardiomyopathy, left ventricular ejection fraction 34 ± 15 %) with refractory VT underwent STAR between January and June 2018. Radioablation was delivered in 82 ± 11 minutes without acute complications. During a mean follow-up of 12 ± 2 months, all patients experienced clinically significant mid-to late-term ventricular arrhythmia recurrence; two patients died of complications associated with their advanced heart failure. There were no clinical or imaging evidence of radiation necrosis or other radiation-induced complications in the organs at risk surrounding the scar targeted by radioablation.ConclusionDespite good initial results, STAR did not result in effective ventricular arrhythmia control in the long term in a selected, high-risk population of patients with scar-related VT. The safety profile was confirmed to be favorable, with no radiation-related complications observed during follow-up. Further studies are needed to explain these disappointing results.

This study describes the technique and outcomes of atrial fibrillation (AF) ablation via a superior approach in patients with interrupted or absent inferior vena cavas (IVCs).In patients with interrupted or absent IVCs, transseptal access cannot be obtained via standard femoral venous access. In these patients, alternative strategies are necessary to permit catheter ablation in the left atrium (LA). This study reports on the outcomes of AF ablation from a superior venous access with a radiofrequency (RF)-assisted transseptal puncture (TSP) technique.This study identified patients with interrupted or absent IVCs who underwent AF ablation via a superior approach at 2 ablation centers from 2010 to 2019.Fifteen patients (mean age: 50.8 ± 11.2 years; 10 men; 10 with paroxysmal AF) with interrupted or absent IVCs underwent AF ablation with transseptal access via a superior approach. Successful TSP was performed either with a manually bent RF transseptal needle (early cases: n = 4) or using a RF wire (late cases: n = 11); this approach permitted LA mapping and ablation in all patients. Mean time required to perform single (n = 8) or double (n = 7) TSP was 16.1 ± 4.8 min, and mean total procedure time was 227.9 ± 120.7 min (fluoroscopy time: 57.0 ± 28.5 min). LA mapping and ablation were successfully performed in all patients.In patients with AF undergoing catheter ablation and who had a standard transseptal approach via femoral venous approach is impossible due to anatomic constraints, RF-assisted transseptal access via a superior approach can be an effective alternative strategy to permit LA mapping and ablation.

Objectives The aim of this study was to assess the feasibility and efficacy of transcatheter leak closure with detachable coils in patients with incomplete left atrial appendage (LAA) closure. Background Incomplete LAA closure is common after interventional therapies targeting the LAA, potentially hindering effective thromboembolic prevention. Detachable coils have found a wide range of applications for transcatheter vascular occlusion and embolization procedures. Methods Thirty consecutive patients at high thromboembolic risk with clinically relevant residual leaks (mean age 72 ± 9 years, 73.3% men, mean CHA2DS2-VASc score 4.4 ± 1.4, mean HAS-BLED score 3.6 ± 0.8) underwent percutaneous closure of the LAA patency using embolization coils. Transesophageal echocardiography was performed at 60 ± 15 days post-procedure. Results LAA closure had been previously attempted with the Watchman device in 25 patients, the Amulet device in 2 patients, and the LARIAT device in 3 patients. Baseline transesophageal echocardiography documented moderate and severe leaks in 20 (66.7%) and 10 (33.3%) patients, respectively. After a single procedure, 25 patients (83.3%) showed complete LAA sealing or minimal leaks. Five patients (16.7%) had moderate residual leaks; 3 patients of them were offered repeat procedures. Mean procedure and fluoroscopy times were 76 ± 41 min and 21 ± 14 min, respectively; the mean volume of iodinated contrast medium used was 80 ± 47 ml. Coil deployment was successful in all cases. The overall complication rate was 6.1%. After a median follow-up period of 54 days (range 43 to 265 days) and an average of 1.1 procedures/patient, transesophageal echocardiography revealed complete LAA sealing or negligible residual leaks in 28 patients (93.3%; 25 with no residual leak, 3 patients with minimal to mild residual leaks) and moderate residual leaks in 2 patients (6.7%). Conclusions Transcatheter LAA leak occlusion using endovascular coils appears to be a safe, effective, and promising approach in patients at high echo time risk with incomplete LAA closure. (Transcatheter Leak Closure With Detachable Coils Following Incomplete Left Atrial Appendage Closure Procedures [TREASURE]; NCT03503253)

Aims Left atrial (LA) scarring, a consequence of cardiac fibrosis is a powerful predictor of procedure-outcome in atrial fibrillation (AF) patients undergoing catheter ablation. We sought to compare the long-term outcome in patients with paroxysmal AF (PAF) and severe LA scarring identified by 3D mapping, undergoing pulmonary vein isolation (PVAI) only or PVAI and the entire scar areas (scar homogenization) or PVAI+ ablation of the non-PV triggers. Methods and results Totally, 177 consecutive patients with PAF and severe LA scarring were included. Patients underwent PVAI only ( n = 45, Group 1), PVAI+ scar homogenization ( n = 66, Group 2) or PVAI+ ablation of non-PV triggers ( n = 66, Group 3) based on operator’s choice. Baseline characteristics were similar across the groups. After first procedure, all patients were followed-up for a minimum of 2 years. The success rate at the end of the follow-up was 18% (8 pts), 21% (14 pts), and 61% (40 pts) in Groups 1, 2, and 3, respectively. Cumulative probability of AF-free survival was significantly higher in Group 3 (overall log-rank P

Background: Longstanding persistent (LSP) atrial fibrillation (AF) is the most challenging type of AF. In addition to pulmonary vein isolation, substrate modification and triggers ablation ...

The aim of this study was to evaluate the incidence and clinical implications of leaks (acute incomplete occlusion, early and late reopenings) following LAA ligation with the LARIAT device.Percutaneous LAA ligation with the LARIAT device may represent an alternative for stroke prevention in high-risk patients with atrial fibrillation with contraindications to oral anticoagulation.This was a retrospective, multicenter study of 98 consecutive patients undergoing successful LAA ligation with the LARIAT device. Leaks were defined as the presence of flow as evaluated by transesophageal echocardiography (TEE). TEE was performed during the procedure, at 6 and 12 months, and after thromboembolic events.Leaks were detected in 5 (5%), 14 (15%), and 19 (20%) patients at the 3 time points. During follow-up, 5 patients developed neurological events (4 strokes and 1 transient ischemic attack). Two occurred early (1 fatal stroke and 1 stroke with multiple recurrences in the following months), and TEE was not repeated after the events. The remaining 3 occurred late (after 6 months) and were associated with small leaks (5 mm). In 2 of 3 cases, such a small leak was missed by the standard evaluation on 2-dimensional TEE, being evident only with the aid of 3-dimensional imaging.Incomplete occlusion of the LAA after LARIAT ligation is relatively common and may be associated with thromboembolic events. Proper long-term surveillance with careful TEE should be considered to detect leaks, which can be managed with either resumption of oral anticoagulation or percutaneous transcatheter closure.

Background Focal impulse and rotor modulation (FIRM)-guided ablation targets sites that are thought to sustain atrial fibrillation (AF). Objective The purpose of this study was to evaluate the acute and mid-term outcomes of FIRM-guided only ablation in patients with nonparoxysmal AF. Methods We prospectively enrolled patients with persistent and long-standing persistent (LSP) AF at three centers to undergo FIRM-guided only ablation. We evaluated acute procedural success (defined as AF termination, organization, or ≥10% slowing), safety (incidence of periprocedural complications), and long-term success (single-procedure freedom from atrial tachycardia [AT]/AF off antiarrhythmic drugs [AAD] after a 2-month blanking period). Results Twenty-nine patients with persistent (N = 20) and LSP (N = 9) AF underwent FIRM mapping. Rotors were presents in all patients, with a mean of 4 ± 1.2 per patient (62% were left atrial); 1 focal impulse was identified. All sources were successfully ablated, and overall acute success rate was 41% (0 AF termination, 2 AF slowing, 10 AF organization). There were no major procedure-related adverse events. After a mean 5.7 months of follow-up, single-procedure freedom from AT/AF without AADs was 17%. Conclusion In nonparoxysmal AF patients, targeted ablation of FIRM-identified rotors is not effective in obtaining AF termination, organization, or slowing during the procedure. After mid-term follow-up, the strategy of ablating FIRM-identified rotors alone did not prevent recurrence from AT/AF.

Remote Navigation of Circular Mapping Catheters Introduction Circular mapping catheters (CMC) are an essential tool in most atrial fibrillation ablation procedures. The Vdrive™ with V-Loop™ system enables a physician to remotely manipulate a CMC during electrophysiology studies. Our aim was to compare the clinical performance of the system to conventional CMC navigation according to efficiency and safety endpoints. Methods and Results A total of 120 patients scheduled to undergo a CMC study followed by pulmonary vein isolation (PVI) were included. Treatment allocation was randomized 2:1, remote navigation:manual navigation. The primary effectiveness endpoint was assessed based on both successful navigation to the targeted pulmonary vein (PV) and successful recording of PV electrograms. All PVs were treated independently within and between patients. The primary safety endpoint was assessed based on the occurrence of major adverse events (MAEs) through seven days after the study procedure. Primary effectiveness endpoints were achieved in 295/302 PVs in the Vdrive arm (97.7%) and 167/167 PVs in the manual arm (100%). Effectiveness analysis indicates Vdrive non-inferiority (pnon-inferiority = 0.0405; δ = –0.05) per the Cochran–Mantel–Haenszel test adjusted for PV correlation. Five MAEs related to the ablation procedure occurred (three in the Vdrive arm—3.9%; two in the manual arm—2.33%). No device-related MAEs were observed; safety analysis indicates Vdrive non-inferiority (pnon-inferiority = 0.0441; δ = 0.07) per the normal Z test. Conclusion Remote navigation of a CMC is equivalent to manual in PVI in terms of safety and effectiveness. This allows for single-operator procedures in conjunction with a magnetically guided ablation catheter.

A Focus on Catheter Ablation of Ventricular Arrhythmias VT ablation is based on percutaneous catheter insertion under fluoroscopic guidance to selectively destroy (i.e., ablate) myocardial tissue regions responsible for the initiation or propagation of ventricular arrhythmias. Although the last decade has witnessed a rapid evolution of ablation equipment and techniques, the control over catheter movement during manual ablation has remained largely unchanged. Moreover, the procedures are long, and require ergonomically unfavorable positions, which can lead to operator fatigue. In an attempt to overcome these constraints, several technical advancements, including remote magnetic navigation (RMN), have been developed. RMN utilizes a magnetic field to remotely manipulate specially designed soft-tip ablation catheters anywhere in the x, y, or z plane inside the patient's chest. RMN also facilitates titration of the contact force between the catheter and the myocardial tissue, which may reduce the risk of complications while ensuring adequate lesion formation. There are several non-randomized studies showing that RMN has similar efficacy to manual ablation, while complication rates and total radiation exposure appears to be lower. Although these data are promising, larger randomized studies are needed to prove that RMN is superior to manual ablation of VT.

It is unclear whether isolation of the left atrial posterior wall (LAPW) offers additional benefits over pulmonary vein antrum isolation (PVAI) alone in patients with persistent atrial fibrillation (AF).We sought to determine the impact of PVAI and LAPW isolation (PVAI+LAPW) versus PVAI alone on the outcome of ablation of persistent AF.During the first procedure, PVAI was performed in 20 patients (group 1), whereas in 32 patients (group 2), PVAI was extended to the left atrial (LA) septum and coronary sinus (CS), and isolation of the LAPW was targeted (ePVAI+LAPW). Isolation of the superior vena cava was achieved in both groups. All patients, regardless of arrhythmia recurrence, underwent a second procedure 3 months after the first procedure. In patients with reconnection of pulmonary veins or LAPW, reisolation was performed, and a third procedure was performed 3 months later to verify isolation. Patients entered follow-up only after PVAI (group 1) or PVAI+LAPW (group 2) isolation was proven.At the 1-, 2-, and 3-year follow-up examinations, the rates of freedom from atrial tachyarrhythmia without use of an antiarrhythmic drug were 20%, 15%, and 10% in group 1 and 65%, 50%, and 40% in group 2, respectively (log-rank P.001). The median recurrence-free survival time was 8.5 months (interquartile range 6.5-11.0) in group 1 and 28.0 months (interquartile range 8.5-32.0) in group 2.Proven isolation of the LAPW provides additional benefits over PVAI alone in the treatment of persistent AF and improves procedural outcome at follow-up. However, the ablation strategy of ePVAI+LAPW is still associated with a significant high incidence of very late recurrence of atrial tachyarrhythmia."Outcome of Atrial Fibrillation Ablation After Permanent Pulmonary Vein Antrum Isolation With or Without Proven Left Atrial Posterior Wall Isolation" (LIBERATION). ClinicalTrials.gov Identifier: NCT01660100.

Background: Several distinct risk factors for arrhythmia recurrence and mortality following ventricular tachycardia (VT) ablation have been described. The effect of concurrent risk factors has not been assessed so far; thus, it is not yet possible to estimate these risks for a patient with several comorbidities. The aim of the study was to identify specific risk groups for mortality and VT recurrence using the Survival Tree (ST) analysis method. Methods: In 1251 patients 16 demographic, clinical and procedure-related variables were evaluated as potential prognostic factors using ST analysis using a recursive partitioning algorithm that searches for relationships among variables. Survival time and time to VT recurrence in groups derived from ST analysis were compared by a log-rank test. A random forest analysis was then run to extract a variable importance index and internally validate the ST models. Results: Left ventricular ejection fraction, implantable cardioverter defibrillator/cardiac resynchronization device, previous ablation were, in hierarchical order, identified by ST analysis as best predictors of VT recurrence, while left ventricular ejection fraction, previous ablation, Electrical storm were identified as best predictors of mortality. Three groups with significantly different survival rates were identified. Among the high-risk group, 65.0% patients were survived and 52.1% patients were free from VT recurrence; within the medium- and low-risk groups, 84.0% and 97.2% patients survived, 72.4% and 88.4% were free from VT recurrence, respectively. Conclusions: Our study is the first to derive and validate a decisional model that provides estimates of VT recurrence and mortality with an effective classification tree. Preprocedure risk stratification could help optimize periprocedural and postprocedural care.

ObjectivesThis study sought to characterize ventricular tachycardia (VT) ablation outcomes across nonischemic cardiomyopathy (NICM) etiologies and adjust these outcomes by patient-related comorbidities that could explain differences in arrhythmia recurrence rates.BackgroundOutcomes of catheter ablation of VT in patients with NICM could be related to etiology of NICM.MethodsData from 2,075 patients with structural heart disease referred for catheter ablation of VT from 12 international centers was retrospectively analyzed. Patient characteristics and outcomes were noted for the 6 most common NICM etiologies. Multivariable Cox proportional hazards modeling was used to adjust for potential confounders.ResultsOf 780 NICM patients (57 ± 14 years of age, 18% women, left ventricular ejection fraction 37 ± 13%), underlying prevalence was 66% for dilated idiopathic cardiomyopathy (DICM), 13% for arrhythmogenic right ventricular cardiomyopathy (ARVC), 6% for valvular cardiomyopathy, 6% for myocarditis, 4% for hypertrophic cardiomyopathy, and 3% for sarcoidosis. One-year freedom from VT was 69%, and freedom from VT, heart transplantation, and death was 62%. On unadjusted competing risk analysis, VT ablation in ARVC demonstrated superior VT-free survival (82%) versus DICM (p≤ 0.01). Valvular cardiomyopathy had the poorest unadjusted VT-free survival, at 47% (p< 0.01). After adjusting for comorbidities, including age, heart failure severity, ejection fraction, prior ablation, and antiarrhythmic medication use, myocarditis, ARVC, and DICM demonstrated similar outcomes, whereas hypertrophic cardiomyopathy, valvular cardiomyopathy, and sarcoidosis had the highest risk of VT recurrence.ConclusionsCatheter ablation of VT in NICM is effective. Etiology of NICM is a significant predictor of outcomes, with ARVC, myocarditis, and DICM having similar but superior outcomes to hypertrophic cardiomyopathy, valvular cardiomyopathy, and sarcoidosis, after adjusting for potential covariates.

Objectives This study sought to evaluate the efficacy and safety of using half-normal saline (HNS) as the cooling radiofrequency ablation (RFA) irrigant among patients who had failed prior, standard RFA. Background Effective control of ventricular arrhythmias that arise from mid-myocardium may be refractory to standard RFA. Recent data suggest that delivering fluid with decreased ionic concentration during open-irrigated RFA can produce deeper RFA lesions. Methods A 12-center prospective analysis was performed of all ablations using HNS for the treatment of ventricular arrhythmias (premature ventricular complex [PVC]/ventricular tachycardia [VT]) refractory to standard ablation with normal saline irrigant. Results HNS RFA was used clinically to target 94 PVC/VTs refractory to standard ablation. Acute success was achieved in 78 of 94 (83%), with longer-term success occurring in 78 subjects after a mean follow-up of 6.1 ± 6.7 months (range, 3.0 to 25.2 months). Steam pops were observed among 12 (12.6%) patients. There were no significant changes in electrolytes measured before and after the use of HNS, and there were no complications related to HNS use. Conclusions The use of HNS instead of normal saline irrigant during high-power delivery targeting deep myocardial substrate is safe and effective. PVC/VT sources previously unaffected by standard ablation may be successfully ablated with improved efficiency of radiofrequency delivery using HNS.

Background Catheter ablation reduces ventricular tachycardia (VT) recurrence and implantable cardioverter defibrillator shocks in patients with VT and ischemic cardiomyopathy. The most effective catheter ablation technique is unknown. Objectives This study determined rates of VT recurrence in patients undergoing ablation limited to clinical VT along with mappable VTs (“clinical ablation”) versus substrate-based ablation. Methods Subjects with ischemic cardiomyopathy and hemodynamically tolerated VT were randomized to clinical ablation (n = 60) versus substrate-based ablation that targeted all “abnormal” electrograms in the scar (n = 58). Primary endpoint was recurrence of VT. Secondary endpoints included periprocedural complications, 12-month mortality, and rehospitalizations. Results At 12-month follow-up, 9 (15.5%) and 29 (48.3%) patients had VT recurrence in substrate-based and clinical VT ablation groups, respectively (log-rank p Conclusions An extensive substrate-based ablation approach is superior to ablation targeting only clinical and stable VTs in patients with ischemic cardiomyopathy presenting with tolerated VT. (Ablation of Clinical Ventricular Tachycardia Versus Addition of Substrate Ablation on the Long Term Success Rate of VT Ablation (VISTA); NCT01045668 )

Background— We examined the influence of catheter ablation and periprocedural anticoagulation regimen on trajectory of migraine in atrial fibrillation patients with or without migraine history. Methods and Results— Forty patients with (group 1: 64±8 years; men 78%) and 85 (group 2: 61±10 years; men 73%) without migraine history undergoing atrial fibrillation-ablation were enrolled. Migraine status and quality of life were evaluated using standardized questionnaires. Diffusion magnetic resonance imaging of brain was performed for all at pre and 24 hours post procedure. Catheter ablation was performed with (88, 70%) or without (37, 30%) continuous warfarin treatment. Fifty-four patients (11 and 43 from groups 1 and 2, respectively) had subtherapeutic international normalized ratio on procedure day. At 17±5 months follow-up, from group 1, 25 (63%) reported no migraine, 10 (25%) had P P Conclusions— In most patients, migraine symptoms improved substantially after catheter ablation. Interestingly, the only cases of new migraine and aggravation of pre-existent headache had subtherapeutic international normalized ratio during the procedure and new cerebral infarcts.

AIMS This study investigated the impact of weight loss in longstanding persistent (LSPAF) patients undergoing catheter ablation (CA). METHODS Ninety consecutive obese LSPAF patients were approached; 58 volunteered to try weight loss interventions for up to 1 year (group 1), while 32 patients declined weight loss interventions and were included as a control (group 2). Both groups remained on antiarrhythmic drugs. If they continued to experience AF, CA was performed. Body weight was measured at 6-month intervals and arrhythmia status was assessed by event recorder, electrocardiogram (ECG), and Holter monitoring. Symptom severity and quality of life (QoL) were evaluated by AFSS and SF-36 survey, respectively. A scoring algorithm with two summary measures, physical component score (PCS) and mental component score (MCS), was prepared for QoL analysis. RESULTS Significant reduction in body weight (median -24.9 (IQR -19.1 to -56.7) kg, P

Aims Superior vena cava (SVC) isolation might be difficult to achieve because of the vicinity of the phrenic nerve (PN) and sinus node. Based on its embryogenesis, we hypothesized the presence of preferential conduction from the right atrial (RA) posterior wall, making it possible to isolate the SVC antrally, sparing its anterior and lateral aspect. Methods and results This is a descriptive cohort study of 105 consecutive patients in which SVC isolation was obtained with radiofrequency ablation, starting in the septal aspect of the SVC-RA junction and continued posteriorly and inferiorly targeting sites of early activation until electrical isolation was obtained. Acute SVC isolation was achieved in 103 (98%) patients; the mean distance between the site of SVC isolation and the SVC-RA junction was 19.9 ± 5.3 (range 9.7-33.7) mm. During follow-up, 2 (2%) patients developed symptomatic diaphragmatic paralysis due to transient right PN injury; 13 patients underwent a repeat ablation: SVC reconnection was observed in 5 patients, and re-isolation was easily achieved by targeting the corresponding sites of early activation. Conclusion Superior vena cava isolation can be completed by targeting its septal segment and sites of early activation in the posterior SVC-RA junction and RA posterior wall; this is a feasible alternative ablation strategy in patients in which SVC isolation cannot be completed with the standard approach. The risk of sinus node injury or SVC stenosis are eliminated; PN injury is still possible but can easily be prevented with high-output pacing to exclude a true posterior course of the PN.

Background Successful ventricular tachycardia (VT) ablation is associated with improved survival in patients with heart failure. However, the safety and efficacy of VT ablation in the elderly, a population with higher competing nonsudden death risk and comorbidities, have not been well defined. Methods and Results The International Ventricular Tachycardia Center Collaborative Study Group registry of 2061 patients who underwent VT ablation at 12 international centers was analyzed. Kaplan–Meier analysis was used to estimate survival of patients ≥70 years with and without VT recurrence. Of the 2049 patients who met inclusion criteria, 681 (33%) patients were ≥70 years of age (mean age, 75±4 years). Among these, 92% were men, 71% had ischemic VT, and 42% had VT storm at presentation. Mean (±SD) left ventricular ejection fraction was 30±11%. Compared with patients P =0.01) and 1-year mortality (15% versus 11%; P =0.002) but a similar incidence of VT recurrence at 1 year (26% versus 25%; P =0.74) and time to VT recurrence (280 versus 289 days; P =0.20). Absence of VT recurrence during follow-up was strongly associated with improved survival in patients ≥70 years. Conclusion VT ablation in the elderly is feasible and reasonably safe with a modestly higher in-hospital and 1-year mortality, with similar rates of VT recurrence at 1 year compared with younger patients. Successful VT ablation, that is, lack of VT recurrence, is strongly associated with improved survival even in this elderly subgroup.

Background— Ventricular tachycardia (VT) radiofrequency ablation has been associated with reduced VT recurrence and mortality, although it is typically not considered among New York Heart Association class IV (NYHA IV) heart failure patients. We compared characteristics and VT radiofrequency ablation outcomes of those with and without NYHA IV in the International VT Ablation Center Collaboration. Methods and Results— NYHA II–IV patients undergoing VT radiofrequency ablation at 12 international centers were included. Clinical variables, VT recurrence, and mortality were analyzed by NYHA IV status using Kaplan–Meier analysis and Cox proportional hazard models. There were significant differences between NYHA IV (n=111) and NYHA II and III (n=1254) patients: NYHA IV had lower left ventricular ejection fraction; more had diabetes mellitus, kidney disease, cardiac resynchronization implantable cardioverter–defibrillator, and VT storm despite greater antiarrhythmic drug use ( P Conclusions— Despite greater baseline comorbidities, VT radiofrequency ablation can be safely performed among NYHA IV patients. Early VT recurrence is significantly associated with subsequent mortality regardless of NYHA status. Elimination of recurrent VT in NYHA IV patients may reduce mortality to a level comparable to NYHA II and III with arrhythmia recurrence.